Workflow — Regulatory Submission

Submissions reviewed before they go out the door.

FDA, SEC, FINRA, and FERC filings — completeness checked against agency rules, prior-submission consistency validated, confidential-business-information redaction applied, defects flagged. Tracked-change markup and submission package into FDA ESG, SEC EDGAR, FINRA Gateway, or FERC eFiling. Replaces regulatory paralegals and ALSPs at a fraction of the per-submission cost.

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$45–$95

Per hour, regulatory paralegal at the firm or ALSP

Major federal agencies (FDA, SEC, FINRA, FERC)

60–85%

Volume off the paralegal line after AI cutover

What This Replaces

The Regulatory Paralegal Stack on Every Filing Cycle

The work the regulatory paralegal does on every submission package — and the cost of leaving it there.

The labor

Regulatory submission review today moves through paralegals at deal counsel firms, ALSPs at UnitedLex, Axiom, Elevate, Integreon, and Big Four NewLaw arms (Deloitte Legal, EY Law, KPMG Law, PwC NewLaw). Regulatory paralegals cost $45–$95 per hour billed; structured ALSP engagements often run $5K–$50K per filing cycle. A complex SEC registration statement or FDA NDA section can absorb hundreds of paralegal-hours before it goes out the door.

The cycle time

Standard submission review takes 1–3 weeks at the paralegal stack, with longer cycles when the submission spans multiple agency rules and when prior-submission consistency requires reconstruction across years of correspondence. Every week the submission isn't out the door is a week the registration window narrows, the agency clock keeps running, and prior-submission inconsistencies stay buried in a folder no one has read recently.

The Workflow

Input · Analysis · Output

What goes into submission review, what we do to it, and what shows up in the agency portal.

Input

Submission package and prior history

Draft submission (NDA, IND, 510(k), 10-K, S-1, ATS-N, FERC tariff)
Supporting exhibits, schedules, and appendices
Prior agency correspondence and meeting minutes
Prior submissions and amendments
Agency rules, guidance documents, and form instructions
Confidential business information (CBI) flags
Internal review comments and counsel markup

Analysis

Check, validate, redact

Completeness check against agency rules and form instructions
Prior-submission consistency review (statements, exhibits, financials)
Confidential business information redaction per agency standards
Defect identification (missing items, inconsistent data, format errors)
Cross-reference validation across exhibits and schedules
Filing-deadline and effectiveness-date calculations
Confidence score per finding; exceptions to attorney queue

Output

Tracked-change package + submission

Tracked-change markup of the draft submission
Submission-ready package per agency portal requirements
FDA ESG (eCTD format)
SEC EDGAR (HTML and XBRL)
FINRA Gateway / FINRA eFOCUS
FERC eFiling (XSD-validated XML)
Internal review memo with defect log

Side by Side

Regulatory Submission Review Today vs. With Last Rev

The numbers that matter: cycle time, per-submission cost, accuracy, and audit posture.

Dimension	Regulatory Paralegal / ALSP	Last Rev Regulatory Submission Review
Cycle time, draft to submission-ready package	1–3 weeks at the paralegal stack	1–4 days
Per-hour or per-submission cost	$45–$95/hour or $5K–$50K per filing cycle	Per-submission, benchmarked at 25–45% of paralegal-stack unit cost
Prior-submission consistency review	Manual, time-bounded, often skipped under deadline	Systematic across all prior submissions and correspondence
Audit log per finding	Reviewer notes, no finding-level lineage	Source clause + agency rule + model version + confidence per finding
CBI redaction posture	Manual redaction per CBI flag, frequent over-redaction	Redaction-candidate identification with basis cited per agency standards
Agency-portal integration	Manual upload, format conversion offline	eCTD, EDGAR, Gateway, eFiling format-validated package ready for upload
Renegotiation leverage at next ALSP renewal	None — you're locked in	60–85% of routine submission volume off the contract

How It Works

From Draft to Submission-Ready Package

Five steps. Every one logged. Every one reversible if your confidence threshold isn't met.

Submission Lands

Draft submission, supporting exhibits, prior agency correspondence, and prior submissions from the regulatory team. Agency rules and form instructions for the relevant submission type indexed during onboarding.

Extraction & Classification

Completeness check against agency rules and form instructions. Prior-submission consistency review across statements, exhibits, and financials. CBI redaction candidates identified per agency standards. Defects classified by severity.

Validation Against Agency Rules

Findings validated against the relevant agency rule (FDA 21 CFR, SEC Reg S-K and Reg S-X, FINRA rule book, FERC tariff requirements). Anything below your confidence threshold per finding is routed to a human exception queue — your call which queue, ours or yours.

Push to Agency Portal Format

Tracked-change markup and submission-ready package delivered in the format the agency portal requires — FDA ESG (eCTD), SEC EDGAR (HTML/XBRL), FINRA Gateway, FERC eFiling (XSD-validated XML). Internal review memo with defect log for the regulatory team.

Audit Log Persisted

Every completeness check, consistency finding, and redaction decision logged with the source paragraph, agency rule citation, model version, prompt, and confidence score. Discovery-ready and yours.

Compliance & Defensibility

Built to Meet the Quality Bar Regulatory Counsel Already Runs On

Agency rule conformance

FDA 21 CFR (Drugs, Devices, Biologics, IND, NDA, 510(k), De Novo); SEC Reg S-K, Reg S-X, Form 10-K, S-1, S-3; FINRA rule book and ATS-N requirements; FERC tariff and Form 1 requirements. Agency rule citations are configurable per submission type and update with rule changes.

Prior-submission consistency posture

Statements in the current submission cross-checked against statements in prior submissions and prior agency correspondence. Inconsistencies flagged with the source-and-target citation so regulatory counsel makes the call on a richer file than the paralegal stack delivers today.

CBI redaction defensibility

Redaction candidates identified per the relevant agency standard (FDA 21 CFR 20.61, SEC Rule 24b-2 confidential treatment, FERC CEII, FINRA confidential filing rules). Each redaction has a basis cited so the agency challenge has a defensible answer.

Filing confidentiality & data residency

Pre-filing submissions, draft language, and prior agency correspondence are confidential. Deployable in your VPC or our SOC 2 environment. Encryption in transit and at rest; retention policies tied to your filing lifecycle and post-filing retention rules.

Common Questions

What Regulatory Counsel Asks About Submission Review

Workiva and Veeva Vault are submission-prep and management platforms; EDGAR Online is the SEC filing layer. The competitor on this page is the regulatory-paralegal line on your operating budget — paralegals at deal counsel firms or ALSPs at UnitedLex, Axiom, Elevate, Integreon, or Big Four NewLaw arms billed at $45–$95 per hour or $5K–$50K per filing cycle. We undercut that labor cost, integrate directly into your existing submission-prep platform, and deliver tracked-change markup and submission-ready packages into the agency-portal format.

Contract review handles routine inbound third-party paper. M&A due diligence is a deal-bound workstream. Regulatory submission review is the focused workflow on agency-bound filings — completeness against agency rules, prior-submission consistency, and CBI redaction. Different scopes, different deliverables, different defensibility bar. We built each as a separate page so the workflow stays specific to what regulatory counsel buys.

FDA (drugs, devices, biologics — IND, NDA, BLA, 510(k), De Novo, PMA, 483 responses), SEC (1933 Act, 1934 Act, IA Act, IC Act registration and reporting), FINRA (rule-book filings, ATS-N, member supervisory submissions), and FERC (tariff filings, Form 1, eFiling). Agency rule updates are tracked through agency rule-making feeds and reflected in the validation engine within days of effective dates. Other agencies (CFTC, EPA, NRC) can be added as configurable rule sets per matter.

Most regulatory practices keep the arrangement in place during pilot and early production — we route exceptions, novel agency situations, and submissions that genuinely require senior-paralegal judgment to the team you already have. Volume to the paralegal stack drops 60–85% on routine submission review once cutover completes. You renegotiate at the next renewal from a much better position, or shift the relationship to higher-complexity work like agency negotiations or pre-submission meetings.

Our pilot success threshold is completeness-check and consistency-review accuracy at parity with or above your incumbent paralegal stack, measured on the same shadow-data sample of submissions and validated against the regulatory team's calibration set. Anything below your defined confidence threshold per finding is routed to a human exception queue — your call which queue, ours or yours.

CBI redaction candidates are identified per the relevant agency standard (FDA 21 CFR 20.61, SEC Rule 24b-2 confidential treatment, FERC CEII, FINRA confidential filing rules). Each redaction has a basis cited so the agency challenge has a defensible answer. We don't make the final CBI call — we surface candidates with the basis so regulatory counsel makes the determination on a richer file.

Submission-review pilots typically run 4–6 weeks: 1 week of integration, agency-rule mapping, and submission-template calibration with the regulatory team; 2–3 weeks of shadow-mode running on draft submissions with no portal-side writes; 1–2 weeks of supervised cutover. Production rollout is staged after the pilot meets your accuracy and SLA bar.

We benchmark against your current per-hour paralegal cost ($45–$95) or per-submission ALSP engagement ($5K–$50K). Our target is 25–45% of that unit cost at higher accuracy and faster cycle time. Pricing structures around volume tiers and outcome SLAs, not hourly billable rates.

Two Ways to Start

Take the AI assessment for a structured read on regulatory-submission feasibility for your practice. Or talk to us if you already know which agency line is bleeding the most paralegal labor cost.

Self-serve · 8 minutes

Take the AI Assessment

A short structured assessment that maps your monthly submission volume, the agencies involved, and your paralegal or ALSP arrangement to AI feasibility and ROI.

Talk to a specialist

Get a Per-Submission ROI Model

Send us your monthly submission volume, the agencies involved, and your paralegal or ALSP arrangement. We'll come back with a per-submission unit-cost comparison and a pilot plan in 5 business days.

Other Workflows

More Legal Workflows We Replace

The same approach, applied to the other document-heavy labor lines on your legal-ops or ALSP budget.

HSR & Antitrust Filing Prep

HSR threshold analysis, item-by-item form prep, and 4(c)/4(d) document collection drafted before the deal team grinds to a halt.

Covenant Review

Credit agreements abstracted for financial covenants, baskets, EBITDA add-backs, and reporting requirements — into your compliance system.

M&A Due Diligence Review

Data-room contracts triaged for change-of-control, MAC/MAE, and indemnification — issues list into Intralinks or Datasite in days.

Contract Review

Third-party paper reviewed against your playbook — clauses extracted, deviations flagged, redlines drafted into iManage or NetDocuments.